Seal port with blood collector

ABSTRACT

An access assembly for insertion through a single incision is provided. The access assembly includes a foam body having a proximal end and a distal end and a plurality of lumens extending through the foam body. Each of the lumens includes a sleeve extending the length of the body. The foam body has a central portion and a lower rim at a distal end of the central portion. The lower rim defines a circular recess, about the body, along a proximal side of the lower rim.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/031,352 filed Feb. 21, 2011, which claims the benefit of and priorityto U.S. Provisional Application Ser. No. 61/355,379 filed on Jun. 16,2010, and the disclosures of each of the above-identified applicationsare hereby incorporated by reference in their entirety.

BACKGROUND

Technical Field

The present disclosure relates to a flexible access assembly for use insingle incision surgical procedures. More particularly, the presentdisclosure relates to a flexible access assembly having a mechanism forthe removal of bodily fluids.

Background of Related Art

Today, many surgical procedures are performed through small incisions inthe skin, as compared to the larger incisions typically required intraditional procedures, in an effort to reduce both trauma to thepatient and recovery time. Generally, such procedures are referred to as“endoscopic”, unless performed on the patient's abdomen, in which casethe procedure is referred to as “laparoscopic”. Throughout the presentdisclosure, the term “minimally invasive” should be understood toencompass both endoscopic and laparoscopic procedures.

During a typical minimally invasive procedure, surgical objects, such assurgical access devices (e.g., trocar and cannula assemblies) orendoscopes, are inserted into the patient's body through the incision intissue. In general, prior to the introduction of the surgical objectinto the patient's body, insufflation gases are used to enlarge the areasurrounding the target surgical site to create a larger, more accessiblework area. Accordingly, the maintenance of a substantially fluid-tightseal is desirable so as to prevent the escape of the insufflation gasesand the deflation or collapse of the enlarged surgical site.

To this end, various access devices with valves and seals are usedduring the course of minimally invasive procedures and are widely knownin the art. However, a continuing need exists for surgical accessdevices that can facilitate the accessibility of an underlying tissuesite with relative ease and with minor inconvenience for the surgeon.

SUMMARY

Accordingly, an access assembly for insertion through a single incisionis disclosed herein. The access assembly includes a body, e.g., a foambody, having a proximal end and a distal end and a plurality of lumensextending through the foam body, each of the lumens including a sleeveextending at least a portion of the length of the body. The foam bodyincludes a central portion and a lower rim at a distal end of thecentral portion. The lower rim defines a circular recess, about thebody, along a proximal side of the lower rim.

The body has an upper rim at a proximal end of the central portion. Boththe lower rim and an upper rim have a diameter greater than a diameterof the central portion. The access assembly may define four lumens. Thesleeves are integrally formed with the body, or instead, the sleeves maybe securely affixed with the body. The sleeves may be formed from onepolymer and plastic. The sleeves may define a circular cross-section.The sleeves may include a braided material. The access assembly mayfurther include one or more cannula assemblies inserted through theplurality of lumens. The body may include a Parylene coating. Variousother coatings, e.g., hydrophilic, hydrophobic, bio-agents,anti-infection, analgesic, may also be employed.

DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith reference to the drawings, wherein:

FIG. 1 is a perspective view of an embodiment of an access assemblyaccording to the present disclosure;

FIG. 2 is a top view of the access assembly of FIG. 1;

FIG. 3 is a cross-sectional side view of the access assembly of FIGS. 1and 2 taken along line 3-3 of FIG. 2;

FIG. 4 is a perspective view of a tissue section having an incisiontherethrough with an underlying body organ shown in phantom;

FIG. 5 is a perspective view of the access assembly of FIG. 1 preparedfor insertion through the incision in the tissue;

FIG. 6 is a perspective view of the flexible access assembly of FIG. 1positioned through the incision in the tissue;

FIG. 7 is a side view, partially shown in cross-section, of the accessassembly of FIG. 1, including a stopcock valve and a pair of cannulaassemblies received therethrough;

FIG. 8 is a perspective view of an alternative embodiment of an accessassembly according to the present disclosure;

FIG. 9 is a top view of the access assembly of FIG. 10; and

FIG. 10 is a cross-sectional side view of the access assembly of FIGS. 9and 10 taken along line 10-10 of FIG. 9.

Other features of the present disclosure will become apparent from thefollowing detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, theprinciples of the present disclosure.

DETAILED DESCRIPTION

Embodiments of the presently disclosed access assembly will now bedescribed in detail with reference to the drawings wherein like numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term “proximal” refers to that partor component closer to the user or operator, i.e. surgeon or physician,while the term “distal” refers to that part or component further awayfrom the user.

One type of minimal invasive surgery described herein is multipleinstrument access through a single surgical port. This technique is aminimally invasive surgical procedure, which permits a surgeon tooperate through a single entry point, typically the patient's navel. Thedisclosed procedure involves insufflating the body cavity with a housingmember positioned within an opening in the patient's skin. Instrumentsincluding an endoscope and additional instruments such as graspers,staplers, forceps or the like may be introduced within the port to carryout the surgical procedure. The presently disclosed access port may beused with a surgically created incision, a naturally occurring openingsuch as the anus or the vagina, or in non-laparoscopic procedures.

Referring to FIGS. 1-3, there is disclosed an access assembly 10 for usein single incision surgery. Access assembly 10 is flexible orcompressible to allow it to be inserted through a single incision in thebody of a patient such that after insertion it will expand and sealwithin the incision. Additionally, the flexible nature of accessassembly 10 allows surgical instruments inserted therethrough to bemanipulated about their axes and thus allow a higher degree of movementof the surgical instruments to orient them relative to the tissue beingoperated upon.

Still referring to FIGS. 1-3, access assembly 10 includes a flexiblebody or housing 12 defining a plurality of lumens 16, 18, 20. Body 12may be formed of various materials such as, for example, silicone,thermoplastic elastomers (TPE), rubber, foam, gel, etc. In this manner,body 12 of access assembly 10 may be compressed or squeezed and insertedthrough an incision in the body of a patient. In one embodiment, body 12includes TPE material that is infused with an inert gas, e.g. CO₂ ornitrogen, to form a foam structure. Body 12 may be coated with alubricant, e.g. Parylene N or C, in order to create a lubricious surfacefinish on all external surfaces. Various other coatings, e.g.,hydrophilic, hydrophobic, bio-agents, anti-infection, analgesic, mayalso be employed. In this manner, the coating facilitates insertion ofbody 12 into an incision and insertion of cannula assemblies (FIG. 7)therethrough.

With reference still to FIGS. 1-3, body 12 defines a substantiallyhourglass shape when viewed from the side, including a central portion22 having an upper rim 24 located at a proximal end 26 of centralportion 22 and a lower rim 28 located at a distal end 30 of centralportion 22. Upper rim 24 and lower rim 28 aid in preventing movement ofaccess assembly 10 longitudinally through the incision “I” (FIG. 4) inthe patient. The lower rim 28 defines a circular recess 40 along aproximal side 41 of the lower rim 28. The recess 40 encircles the body12 to form a circular indentation completely about the body 12.

A vertical lumen 42 extends through the body 12 and connects with ahorizontal lumen 44 to produce a longitudinal passageway 43 that extendsfrom the proximal end 26 of the central portion 22 to a horizontalpassageway 45 that extends into the recess 40. It is contemplated thatpassageway 43 and/or passageway 45 may be coated with an anti-coagulant.

As disclosed, the recess 40 is defined by a semi-circular cross-section.However, it is contemplated that any cross-sectional shape may be used.It is also contemplated that the horizontal lumen 44 may intersect withthe recess 40 from any relative position, including along a bottom ofthe recess 40. It is further contemplated that the cross-sectional shapemay vary about a circumference of the recess 40.

Lumens 16, 18, 20 extend through body 12 and define longitudinal axesconfigured to receive a cannula assembly 50 (FIG. 7), a valve assembly60 and/or other insufflation apparatus. As shown, lumens 16, 18, 20include sleeves 16 a, 18 a, 20 a, respectively, extending the length ofbody 12. Sleeves 16 a, 18 a, 20 a may be integrally formed with body 12,or instead may be securely affixed to body 12 using adhesive, ultrasonicwelding or other suitable means. Sleeves 16 a, 18 a, 20 a are formed ofa plastic, polymer or other suitable material and are configured toprevent tearing of body 12 as a cannula assembly or other apparatus isinserted therethrough. Sleeves 16 a, 18 a, 20 a are typically formed ofa harder or less flexible material than body 12 to resist stretching.Sleeves 16 a, 18 a, 20 a may also be coated with a lubricant to assistin insertion of cannula assemblies 50 and/or valve assembly 60.

Referring now to FIGS. 4-7, the use of access assembly 10 in a singleincision surgical procedure will now be described. Although accessassembly 10 will be described as relates to relates to a procedure forexcising and removing a body organ, the aspects of the presentdisclosure may be modified for use in any closed procedure and shouldnot be read as limited to the procedure herein described.

Referring initially to FIG. 4, a single incision “I” is formed through abody tissue “T” and above a body organ, such as, for example, kidney“K”. Turning now to FIG. 5, once incision “I” has been formed throughbody tissue “T”, body 12 of access assembly 10 is squeezed or compressedto reduce body 12 to a relatively smaller diameter for insertion throughincision “I”. As noted hereinabove, body 12 is formed of a flexiblematerial which allows access assembly 10 to be compressed. It should berecognized that the body 12 may be compressed into any suitableconfiguration prior to being inserted into an incision, not merely theconfiguration shown in FIG. 5. For example, in an embodiment, prior toinsertion the body 12 is clamped at its distal end while the proximalend of the housing 12 remains essentially uncompressed, and the clampeddistal end is inserted into the incision.

Referring to FIG. 6, once flexible access assembly 10 has been insertedthrough incision “I”, pressure on body 12 is released, allowing body 12to return towards its initial uncompressed state within incision “I”.Typically, the incision “I” is formed having a size that is smaller thanthe diameter of the initial uncompressed state of the housing 12. Inthis manner, when in place within the incision “I”, the housing 12contacts and presses against the inner surface of the incision “I”,thereby retracting the opening and sealing with the incision “I”. Sinceincisions are often slit-shaped when formed, the portion of the housing12 that is located within the incision may be somewhat oval-shaped (whenviewed from above). As noted hereinabove, body 12 includes upper rim 24and lower rim 28 to prevent migration of access assembly 10 throughincision “I” in body tissue “T”.

Turning to FIG. 7, once access assembly 10 has been positioned abovekidney “K”, cannula assemblies 50 and/or valve assembly 60 may beinserted through seal lumens 16, 18, 20 to operate on kidney “K”.Cannula assembly 50 includes a housing 52 configured to sealinglyreceive an instrument 5 and an elongated cannula 52 configured to extendthrough one of lumens 16, 18, 20. Housing 52 may include an insufflationport 53. Although shown including cannula assembly 50, any cannulaassembly capable of being received through lumens 16, 18, 20 may be usedwith access assembly 10. Valve assembly 60 is configured to be receivedthrough one of lumens 16, 18, 20. Valve assembly 60 may include astopcock or other type of valve 62 for selectively providinginsufflation gas through access assembly 10. Although shown includingvalve assembly 60, any valve assembly capable of sealed reception withinlumens 16, 18, 20 may be used with access assembly 10.

Still referring to FIG. 7, once the body cavity has been properlyinsufflated, either through valve assembly 60 or insufflation port 53 ofcannula assembly 50, kidney “K” may be operated upon to excise it fromthe surrounding tissue. One or more surgical instruments, such as, forexample, tissue graspers or surgical staplers, are inserted through andmanipulated within cannula assemblies 50 to complete the procedure. Asshown, instrument 5 may be inserted and retracted, in the direction ofarrows “A”, through any of seal lumens 16, 18, 20 that have received acannula assembly 50 therethrough. Due to the flexible nature of accessassembly 10, cannula assembly 50 may be flexed relative thereto. In thismanner, once instrument 5 is inserted through cannula assembly 50, aproximal end 5 a of instrument 5 may be manipulated in any direction, asindicated by arrows “B”. Thus, access assembly 10 permits a surgeon tomanipulate or orient instrument 5 at various locations relative to thetissue being operated upon. Cannula assemblies 50 may also be flexedrelative to each other. In this manner, a first instrument insertedthrough a first cannula assembly may be manipulated relative to a secondinstrument inserted through a second cannula assembly.

With continued reference to FIG. 7, the recess 40 functions to collectbodily fluids 48 from the incision “I”. A vacuum source 64 may beconnected with the vertical lumen 42, which is connected with the recess40 by the horizontal lumen 44. As a result, any bodily fluids 48 thatare collected within the recess 40 can be removed. Thus, bodily fluids48 may be collected and dispensed with during a minimally invasivesurgical procedure to aid in the prevention of contamination and visualimpairment of the surgical work site.

Upon completion of the procedure, cannula assemblies 50 and valveassembly 60 are removed from respective lumens 16, 18, 20. Accessassembly 10 is then compressed or squeezed such that it may be removedfrom incision “I”. Incision “I” is then closed in a conventional manner.

Turning now to FIGS. 4-6, an alternative embodiment of an accessassembly according to the present disclosure is shown generally asaccess assembly 110. Access assembly 110 is substantially similar toaccess assembly 10 described hereinabove, and will only be described asrelates to the differences therebetween. Access assembly 110 includes abody 112 defining a plurality of lumens 116, 118, 120. Each of lumens116, 118, 120 includes a sleeve 116 a, 118 a, 120 a, respectively. Eachof sleeves 116 a, 118 a, 120 a is formed of a braided mesh. As withsleeves 16 a, 18 a, 20 a, described hereinabove, sleeves 116 a, 118 a,120 a are configured to prevent tearing of body 112 as cannula assemblyand other apparatus are inserted therethrough.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, as noted hereinabove, thedisclosed flexible access assembly may be provided with multiple lumensin excess of the disclosed three lumens. Additionally, the diameters orconfiguration of the disclosed lumens need not be identical but may bevaried depending upon the contemplated surgical instruments to beutilized therethrough. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended hereto.

1-11. (canceled)
 12. An access assembly for insertion through tissue,comprising: a body formed of a flexible material, the body including aproximal end and a distal end having a distal rim, the body defining afluid lumen extending between the proximal end and the distal rim, thefluid lumen including an opening on a proximal side of the distal rim,the distal rim defining a circular groove on the proximal side thereof,wherein the fluid lumen is in fluid communication with the circulargroove such that the fluid lumen enables extraction of bodily fluidsfrom the circular groove.
 13. The access assembly according to claim 12,wherein the body further defines a lumen extending therethrough, thelumen configured to receive a surgical instrument therethrough.
 14. Theaccess assembly according to claim 13, wherein the body includes asleeve disposed within the lumen.
 15. The access assembly according toclaim 14, wherein the sleeve is integrally formed with the body.
 16. Theaccess assembly according to claim 14, wherein the sleeve is formed of abraided mesh.
 17. The access assembly according to claim 12, wherein thebody is formed of at least one of silicone, thermoplastic elastomer,rubber, foam, or gel.
 18. The access assembly according to claim 12,wherein the body further defines a passage extending between a distalend of the fluid lumen and the circular groove to provide fluidcommunication therebetween.
 19. The access assembly according to claim12, wherein the body has a substantially hourglass shape.
 20. The accessassembly according to claim 12, wherein the circular groove extendsdistally from the proximal side of the distal rim.
 21. An accessassembly for insertion through tissue, comprising: a body including aproximal end and a distal end having a distal rim, the body defining: acircular groove extending distally from a proximal side of the distalrim; a fluid lumen extending between the proximal end and the distalrim; and a passage extending between the circular groove and a distalportion of the fluid lumen such that the fluid lumen is in fluidcommunication with the circular groove.
 22. The access assemblyaccording to claim 21, further comprising a vacuum source in fluidcommunication with the fluid lumen to extract bodily fluids from thecircular groove.
 23. The access assembly according to claim 21, whereinat least one of the passage or the fluid lumen includes ananti-coagulant.
 24. The access assembly according to claim 21, whereinthe body further defines a lumen configured to receive a surgicalinstrument therethrough.
 25. The access assembly according to claim 21,wherein the body further includes a sleeve.
 26. The access assemblyaccording to claim 25, wherein the sleeve is formed of a braided mesh.27. The access assembly according to claim 21, wherein the body isformed of at least one of silicone, thermoplastic elastomer, rubber,foam, or gel.